NAVIGATE THE FIELD OF MEDICAL DEVICES
Medical devices present a wide-ranging field, and their specific medical purposes vary immensely. It requires two European Regulations – the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR) specifically for medical devices used for in vitro diagnosis – to ensure products meet the standards of quality, safety, and performance.
Adding the fact that a medical device can be anything from an instrument, appliance, or software to an implant or a reagent, it poses a particular challenge to find your way around in this sector.
We support you along the entire medical device life cycle:
From design and development to registration and beyond: We always consider your individual needs, challenges, and potential – and round them off with our knowledge of medical devices, pharmaceuticals, and combination products. Combined with efficient business concepts, we can provide a holistic approach throughout the entire value chain of products and services.
Clinical-Evaluation-
As-A-Service
A medical device needs to be effective and to provide more benefits than risks when used as intended by the manufacturer.
We demonstrate safety and performance of your product by means of a clinical evaluation – both in the initial phase to receive the CE mark and throughout the entire life cycle.
Biocompatibility-
As-A-Service
Obtaining a CE certification for a medical device requires demonstration of compliance with general safety and performance requirements.
Our toxicology specialists and experts on the development of medical devices find the best approach to evaluate your medical device and determine appropriate measures.
Risk-Management-
As-A-Service
For manufacturers it is crucial to implement risk management in their technical documentation.
As your independent partner, THE FORCE can expand your views and assist to tackle the complexities of risk management – and thus guarantee compliance of your risk management and your medical device.
Post-Market-Surveillance-
As-A-Service
Manufacturers have to establish and maintain post-market surveillance as an integral part of their quality management system.
THE FORCE supports you with all elements of the post-market surveillance system and assists you in integrating it into your QMS and thus into the DNA of your company.
PRRC-
As-A-Service
Manufacturers and authorized representatives of medical devices are required to permanently have a person responsible for regulatory compliance (PRRC) at their disposal.
For micro and small enterprises, there's the option to outsource this function – and THE FORCE is ready to take it on for you.
EU-Authorized-Representative-
As-A-Service
Are you a manufacturer who wants to place their medical device on the EU market? Then one of the prerequisites for you is to appoint an EU-Authorized Representative.
THE FORCE takes on that role for you: We help you to bring your product on the market – and ensure safety and compliance throughout the life cycle of your device.
EU-Importer-
As-A-Service
Economic operators placing medical devices on the market have the overall responsibility for the efficacy and safety of the device. For non-EU manufacturers, this role and responsibility falls to the importer.
As THE FORCE, we take on this task and all obligations associated with it for you.
